A Multicenter Clinical Study on the Comparison of the Efficacy of Surfactant and Perinatal Risk Factors in NRDS With Different Gestational Ages
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- therapeutic effect of pulmonary surfactant of infants at different gestational ages
研究概览
简要总结
Since exogenous surfactant replacement therapy was first used to prevent neonatal respiratory distress syndrome (NRDS)，it has become the main method of treatment of NRDS. However, in some infants, death is inevitable despite intensive care and surfactant replacement therapy, especially in near-term and term infants. The first goal of our study is to compare the therapeutic effect of pulmonary surfactant of infants at different gestational ages and to investigate whether exogenous surfactant replacement therapy is effective for all newborns with RDS. The second goal of our study is to further analyze the risk factors and causes of RDS in early preterm infants and near term/term infants.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Hour 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with RDS who received surfactant therapy were recruited between January 2011 and December 2016.
排除标准
- •Infants were excluded if they had any congeni- tal malformation, inherited metabolic abnormality, intrauterine infection, Rh/Rh incompatibility, pneumonia, pulmonary hypertension, meconium aspiration syndrome, or asphyxia.
研究组 & 干预措施
early preterm infants with RDS
gestational age<34 weeks
干预措施: Surfactant, Pulmonary，Curosurf (Drug)
early preterm infants with RDS
gestational age<34 weeks
干预措施: Perinatal risk factors of NRDS (Other)
near term infants with RDS
34 weeks≤gestational age< 37 weeks
干预措施: Surfactant, Pulmonary，Curosurf (Drug)
near term infants with RDS
34 weeks≤gestational age< 37 weeks
干预措施: Perinatal risk factors of NRDS (Other)
term infants with RDS
Gestational age ≥ 37 weeks
干预措施: Surfactant, Pulmonary，Curosurf (Drug)
term infants with RDS
Gestational age ≥ 37 weeks
干预措施: Perinatal risk factors of NRDS (Other)
结局指标
主要结局
therapeutic effect of pulmonary surfactant of infants at different gestational ages
时间窗: January 1，2011 to December 30，2016
次要结局
未报告次要终点
研究者
Li Wang
Daping Hospital
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University